Kornimate/medical-research-clean huggingface dataset:
embolic events detected during total knee arthroplasty with the use of ria (reamer-irrigator-aspirator)

Conditions: Total Knee Replacement

Summary: the embolisation of fat and bone marrow during long bone instrumentation is a well-known complication of major joint replacement surgery. clinically significant venous thromboembolic disease, cardiopulmonary dysfunction,cerebral emboli, and death have all been described. because the intravasation of medullary contents is caused by increased pressure during canal instrumentation, the use of the synthes ria (reamer-irrigator-aspirator), a negative pressure-irrigated high-speed reamer, may result in a lower incidence of embolism. this controlled clinical trial will evaluate the utility of the ria in reducing the frequency and severity of embolic events as detected by intraoperative transesophageal echocardiography (tee) and transcranial doppler (tcd) during total knee arthroplasty (tka) surgery.

patients scheduled to undergo total knee replacement surgery will be randomized to receive reaming with either the synthes ria (intervention group) or standard reamer (control group). all subjects will undergo intraoperative monitoring with transesophageal echocardiography and transcranial doppler ultrasound. both intraoperative and postoperative oxygen saturation levels will be monitored and recorded for evidence of hypoxemia. subjects will be evaluated for evidence of thrombogenesis and systemic inflammation both preoperatively and at selected postoperative intervals.

Eligibility criteria:
inclusion criteria: * subject is 18 years of age or older * scheduled or soon to be scheduled for elective total knee replacement surgery * no previous history of hip or (ipsilateral) knee replacement exclusion criteria: * subject is under 18 * prior instrumentation of the medullary canal (knee or hip) * history of esophageal or gi disease or other contraindication for tee * previous history of dvt * currently on anti-coagulant therapy (i.e. coumadin or others) * currently on supplemental oxygen or spo2 is below 90 on room air * cognitive or language barriers limiting comprehension of study materials in english * subject is pregnant or planning pregnancy * current or impending incarceration

Keywords: knee replacement surgery reamer-irrigator-aspirator femoral reaming fat embolism
immunogenicity after revaccination with 23-valent pneumococcal polysaccharide vaccine: healthy elderly people versus diabetic patients

Conditions: Pneumococcal Infections

Summary: pneumococcal disease causes thousands of infections, such as meningitis, bloodstream infections, pneumonia, and ear infections in us annually. as pneumococcal vaccines provide serotype-specific protection, it is important to induce sufficient immune responses for the most clinically relevant serotypes. all adults aged 65 years or older are recommended to receive ppsv23 vaccination irrespective of underlying medical conditions. thus, since may 2013, south korea introduced ppsv23 in the national immunization program for elderly individuals aged ≥65 years. following ppsv23 vaccination, serotype-specific igg concentrations and opa titers increase and then decline over time thereby decreasing protective efficacy, although these might remain above pre-vaccination levels until 5 years from ppsv23 administration. the decline of pneumococcal immunity may be more prominent among chronically ill patients, including those with diabetes. currently however, revaccination is not recommended. in this study, we aimed to evaluate the serotype specific immunogenicity between healthy elderly people and old adults with diabetes after revaccination with ppsv23 at the age of 70-75 years. serotype-specific igg concentrations and opsonophagocytic killing activity (opa) titers will be assessed.


Eligibility criteria:
inclusion criteria * elderly people aged 70-75 years * had received ppsv23 in the previous 5-7 years exclusion criteria: * immunocompromised patients * subjects receiving immunosuppressive agents * subjects with a history of vaccination with pneumococcal conjugate vaccine * subjects with a history of pneumococcal disease (positive culture from blood or other sterile fluid) * fever (defined as an oral temperature \>37.5℃) within 24 h before ppsv23 vaccination

Keywords: streptococcus pneumoniae diabetes mellitus immunogenicity, vaccine pneumococcal vaccines
prophylactic enoxaparin dosing in roux-en-y gastric bypass surgery patients at st. vincent carmel

Conditions: Obesity

Summary: the purpose of this study is to assess anti-factor xa concentrations in patients given prophylactic enoxaparin after bariatric surgery.

fda-approved enoxaparin dosing for venous thromboembolism (vte) prophylaxis is a fixed-dose regimen irrespective of body mass index (bmi) or actual body weight (abw). clinical trials suggest that dosing may be inadequate for obese patients. we plan to assess anti-factor-xa concentrations in patients who received prophylactic enoxaparin after bariatric surgery. this prospective study will examine 150 anti-factor xa concentrations from patients 18 years or older undergoing primary roux-en-y gastric bypass surgery at st. vincent carmel bariatric center of excellence. patients receive varying prophylactic enoxaparin regimens at the surgeon's discretion. anti-factor-xa concentrations are obtained at steady state.

Eligibility criteria:
inclusion criteria: * patients 18 years and older undergoing primary roux-en-y gastric bypass surgery at st. vincent carmel bariatric center of excellence exclusion criteria: * receiving anticoagulation therapy prior to surgery (i.e. warfarin) * did not receive enoxaparin after surgery

Keywords: prophylactic enoxaparin roux en y gastric bypass surgery
phase 2 trial of bnz-1 in patients with moderate to severe alopecia areata

Conditions: Alopecia Areata; Alopecia Totalis; Alopecia Universalis

Summary: this study is a randomized, double-blind, placebo-controlled, multi-center, dose-ranging study to characterize the efficacy and safety of bnz-1 administered by slow iv push weekly for 3 months to adults diagnosed with moderate to severe alopecia areata, defined as having a \>50% loss of terminal hair on the scalp. the study has three periods: * 30-day screening period * 3-month treatment period * 3-month follow-up period the study will be conducted at approximately 15-20 clinical sites in the united states.


Eligibility criteria:
inclusion criteria: 1. must have a diagnosis of moderate to severe aa defined as the presence of ≥50% total terminal hair loss at baseline as measured using the salt score for \> 6 months, but \<10 yrs. includes alopecia totalis and alopecia universalis 2. patients may be naïve to treatment or have been treated with intralesional (il) steroids or other treatments for aa, with a washout of at least 30 days or 5 times the elimination half-life prior to day 1. 3. prior treatment with a janus kinase (jak) inhibitor (e.g., tofacitinib, ruxolitnib) is allowed, but patients considered refractory to a jak inhibitor are excluded from this trial. exclusion criteria: e subjects from this study if any of the following criteria are met: 1. clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, renal, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult, or that would put the subject at risk by participating in the study in the opinion of the investigator. other active dermatologic conditions, including but not limited to vitiligo, atopic dermatitis, or non-scalp psoriasis are not exclusionary. 2. patients with active inflammatory skin disease on the scalp, including but not limited to psoriasis, seborrheic dermatitis or folliculitis, which cannot be adequately controlled prior to screening. 3. ongoing treatment with an immune system modulator or suppressant that cannot be discontinued prior to screening and at least 30 days or 5-times the elimination half-life prior to treatment. 4. any ongoing topical treatment for alopecia areata 5. history of or currently active primary or secondary immunodeficiency. 6. known active bacterial, viral, fungal, mycobacterial infection, or other infection (including latent tuberculosis \[tb\] unless treatment is documented or atypical mycobacterial disease \[but excluding fungal infection of nail beds, minor upper respiratory tract infection, and minor skin conditions\]), or any major episode of infection that required hospitalization or treatment with iv antibiotics within 60 days of study drug administration or oral antibiotics within 30 days prior to study drug administration. 7. received other investigational products or therapy in the 60 days prior to study drug administration.
encapsulated flavour effects on satiety

Conditions: Overweight

Summary: the purpose of this study is to evaluate the satiating effects of different gummies with encapsulated flavour on overweight subjects (bmi ≥25 and \<30 kg / m2). some studies have shown that the contribution of different flavours could reduce food intake. this have made grown the interest of food industry in incorporate these compounds in food and to being able to develop new functional foods into the control of body weight, as well as variables of glucose metabolism and lipid profile, which can contribute to te prevention of cardiovascular diseases.

a randomized, cross-over and double-blind pilot study with 3 study arms is being performed to evaluate the satiating properties of the encapsulated flavours in different gummies in a group of healthy overweight subjects. the investigators included 12 participants (6 men and 6 women) between 18 and 55 years (bmi ≥25 and \<30 kg / m2). all volunteers will be randomized into 3 study groups, and participants will receive the 3 different study products in order during the 3 experimental phases.

Eligibility criteria:
inclusion criteria: * men and women from 18 to 65 years old. * body mass index (bmi) ≥25 and \<30 kg/m2. * adequate cultural level and understanding for the clinical trial. * signed informed consent exclusion criteria: * subjects with bmi ≥30 or \<25 kg /m2 * subjects diagnosed with diabetes mellitus. * subjects with dyslipidemia on pharmacological treatment * subjects with hypertension on pharmacological treatment * subjects with established diagnosis of eating disorder * smokers or those subjects with high alcohol consumption (\> 2-3 servings/day in men and\> 1 serving/day in women (1 serving = 1 glass of wine or 1 bottle of beer) * subjects under pharmacological treatment (except oral contraceptives) * subjects with large weight fluctuations of more than 4 kg or who have undergone in six months a weight loss diet * subjects with sensory problems * subjects with gastrointestinal diseases that affect the digestion or absorption of nutrients * pregnant or breastfeeding women * women with menstrual irregularities (absence of menstrual cycle at least 2 months) * subjects with intense physical activity. * subjects with food allergies to meals included in breakfast, study product or lunch or that reject their consumption * subjects with a diagnosis of celiac disease or a gluten intolerance

Keywords: satiety encapsulated flavour gummies visual analogue scale cross-over
innovative nutrition and mhealth evidence building project

Conditions: Underweight Children Aged 6-23 Month Old (WAZ < -1)

Summary: the project is the collaboration with the lead agencies national institute of public health, world vision and emory university world vision has a history of successfully implementing "positive deviance/hearth (pdh)" programs across the globe. pdh is a community-based intervention utilizing locally appropriate health and infant feeding practices to rehabilitate underweight children and promote behavioral changes in caregivers. a recent systematic review on the pd/hearth approach found that although some programs show clear success in particular settings, overall, the results were mixed for program effectiveness. furthermore, with the growing use of mobile phones and technology in the world, including cambodia, there have been various studies and a systematic review that found sms reminders and voice recordings to have promising impact on behavior change of patients for smoking cessation and improved adherence to drugs for asthma patients. although there are positive findings around the use of mobile devices to improve behavior change, there has yet to be a study that examines the impact of mobile phones on improving behavior change of caregivers related to nutrition, water, sanitation and hygiene (wash), health, and caring practices, which as a result, would decrease the prevalence of underweight in children 6-23 months of age. this study will provide evidence on the effectiveness of the pdh model in cambodia compared to the current standard of care. investigators believe the pdh approach will be a powerful tool to reduce child malnutrition. in addition, given the intensity and cost burden associated with pdh, investigators will simultaneously test if the intensity of the pdh model can be reduced by introducing an innovative application of mhealth to replace 50% of face-to-face education sessions (5 days) and all follow up visits with mobile support calls. collectively this research will provide critical data to inform program operations on the optimal and most effective method to reduce child underweight in cambodia. in year 1, the purpose of this study is to assess the effectiveness of contextualized messages through pdh programs and a mobile technology (mhealth), to improve knowledge, behaviour change, and level of confidence of caregivers with underweight children aged 6-23 months in feeding, hygiene, health-seeking, and caring practices. in year 2, the study's aim will be to assess the prevention of underweight in the siblings of the children included in the three programs outside of the 360 study subjects from year 1.


Eligibility criteria:
inclusion criteria for enrollment: * child 6-23 months residing in study area and intending to stay in area for study duration * underweight child (weight for age z-score \< -1) exclusion criteria: * no access to mobile phone * severe acute malnutrition (weight for height z-score \<-3), edema
icg vs blue patent for tad in cn1 breast carcinoma after neoadjuvant chemotherapy

Conditions: Breast Cancer; Axillary Metastases

Summary: to validate the use of icg as a tracer during tad in patients with cn1 breast carcinoma after neoadjuvant chemotherapy.

this patient registry is designed to prospectively collect standardized clinical, imaging, surgical, and pathological data from patients with cn1 breast carcinoma undergoing targeted axillary dissection (tad) following neoadjuvant chemotherapy, using indocyanine green (icg) as a lymphatic tracer. to ensure data quality and consistency the following procedures and quality control measures will be implemented: standardized case report forms (crfs): all data will be recorded using electronic crfs developed specifically for the registry. these forms are structured to capture relevant demographic, clinical, radiological, surgical, and pathological variables, including tracer detection rates, number of retrieved nodes, false-negative rates, and complications. center training and accreditation: all participating surgeons and radiologists will receive training on standardized procedures for tad using icg, including injection technique, intraoperative fluorescence detection, and specimen handling. regular inter-institutional meetings will be held to reinforce protocol adherence. quality assurance in imaging and pathology: lymph node localization procedures (e.g., clip placement, imaging review) and histopathological analyses will follow unified protocols. ethics and patient confidentiality: all data will be de-identified and managed in compliance with gdpr and local data protection regulations. informed consent will be obtained from each participant prior to data inclusion. follow-up and outcome tracking: the registry will track short- and mid-term surgical outcomes, including detection rates, surgical complications, and axillary recurrence, ensuring longitudinal quality assessment of the icg-guided tad approach.

Eligibility criteria:
inclusion criteria: * breast cancer cn+ patients who undergo neadjuvant treatment. exclusion criteria: * patients in whom there is a contraindication for the use of icg. * patients in whom there is evidence of progression of the disease after neoadjuvant treatment.
wired: wireless interstage remote device study

Conditions: Congenital Heart Disease in Children; Vital Signs; Pediatrics; Remote Monitoring

Summary: a mixed-methods study will be used to evaluate the use of standard of care periodic pulse oximetry by parents/lar and the feasibility of the collection of physiologic data related to the use of the pediarity system. this system includes the gabi band and software platform (gabi analytics).

after enrollment, parents will be taught by the study team on the use of the pediarity system which includes the placement of the gabi band and the use of the gabi wi-fi monitor application for data transfer. this education by the study team will ensure uniform training and preliminary understanding with teach back on the use of the gabi band and gabi wi-fi monitoring application. parents can ask the study team any use and/or technical questions during this time period. all clinical care questions from standard of care monitoring will go to the champ healthcare team. if parents/lars have a clinical concern from a value on the pediarity system - they will be referred to use their standard of care pulse oximetry before any clinical intervention and care is recommended by the healthcare team. the study team will not make any healthcare or diagnostic recommendations during the monitoring period based on any pediarity system data. the study team will educate parents and lars on the pediarity system. this system does not replace any use of their standard of care pulse oximetry and champ videos. parents may place the gabi band on their child and use the pediarity system at any frequency they choose in the home setting for a length of approximately one month at home (to coordinate when they return to the study site for a care visit). parents can email or teams call the study team directly (during daytime hours m-f) for any technical questions during this the study period. the study team will evaluate clinical data only at the conclusion of the study period and qualitative feedback from the parents will be gathered.

Eligibility criteria:
inclusion criteria: * study participants will be parent-child dyads - pediatric patients who have been diagnosed with congenital, arrhythmic, or acquired heart disease at children's mercy kansas city. * age criteria for children: after birth and who are less than two years of age at the time of being approached. * the child of the parent-child dyad must be planned from the clinical standpoint prior to approach for discharge home with standard of care oxygen saturation/heart rate/pulse oximeter for remote patient monitoring population - and followed with the champ application in the home setting. * champ app cm irb 15030113 - pediatric patients may be followed by the champ clinical team or enrolled in the champ app cardiac study exclusion criteria: * over two years of age at the time of being approached for study participation. * families that do not speak english or spanish (languages supported by the devices). * families that do not have access to a wi-fi network at home.

Keywords: pediatric physiologic vital signs
a study of bv-arau in the treatment of varicella-zoster viral disease (vzv) in hiv-infected children who have not had success with or who cannot take other treatments for vzv

Conditions: HIV Infections; Chickenpox

Summary: to provide oral sorivudine ( bv-arau ) to pediatric hiv-infected patients with varicella-zoster viral disease who have failed or are intolerant of alternative therapy.

any physician qualified to treat pediatric aids patients may enroll patients in this study.

Eligibility criteria:
inclusion criteria patients must have: * hiv infection. * cutaneous, visceral, or ocular varicella-zoster viral infection. * refractory or intolerant to acyclovir or foscarnet therapy. * consent of parent or guardian. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * inability to take oral capsules or tolerate liquids. concurrent medication: excluded: * 5-flucytosine, 5-fluorouracil, high-dose prednisone, or probenecid. patients with the following prior condition are excluded: history of immediate hypersensitivity to nucleoside analogues. prior medication: excluded: * 5-flucytosine, 5-fluorouracil, high-dose prednisone, or probenecid within 4 weeks prior to study entry. required: * prior acyclovir or foscarnet.

Keywords: herpes zoster acquired immunodeficiency syndrome aids-related complex antiviral agents sorivudine chickenpox
clinical trial on treatment of intraventricular hemorrhage

Conditions: Intraventricular Hemorrhage

Summary: the specific objective of this trial is to determine the lowest dose and dose frequency possible with the best pharmacokinetic and safety profile and it's ability to remove a blood clot from the ventricular system.

the purpose of this trial is to determine the efficacy and pharmacokinetics of intraventricular injections of multiple low doses of rt-pa. sixteen subjects were already randomized to receive intraventricular injections of with 0.3 mg or 1.0 mg of rt-pa every 12 hours for up to 8 doses. results of this stage (n=16) were then analyzed and the most effective dose of 1.0 mg was chosen to be used in the second stage (n=36) to determine the optimal frequency of dosing. we propose to test if this intervention facilitates more rapid clot resolution, complete recovery function and decreased mortality from this condition.

Eligibility criteria:
inclusion criteria: 1. age 18-75 2. ivc placed as standard of care using less than or equal to 2 complete passes. 3. spontaneous ich less than or equal to 30 cc. 4. able to receive first dose within 48 hours of ct scan diagnosing ivh (providing the time of symptom onset to diagnostic ct does not exceed 12 hours). 5. clot size measured on ct scan done 6 hours after ivc placement must be equal to the presentation clot size plus or minus 5 cc (as determined by the axbxc)/2 method). 6. on stability ct scan either the 3rd or 4th ventricles are occluded with blood (no evidence of csf flow on ct). 7. sbp \< 200 mmhg sustained for 6 hours. 8. historical rankin of 0 or 1. exclusion criteria: 1. suspected or untreated aneurysm or avm (unless ruled out by angiogram or mra/mri). 2. clotting disorders. 3. patients with platelet count \ 1.7, pt \> 15s, or an elevated aptt. 4. pregnancy (positive pregnancy test). 5. infratentorial hemorrhage (i.e., parenchymal/posterior fossa hematoma; all cerebellar hematomas excluded). 6. sah (an angiogram should be obtained when the diagnostic ct scan demonstrates subarachnoid hemorrhage or any hematoma location or appearance not strongly associated with hypertension. if the angiogram does not demonstrate a bleeding source that accounts for the hemorrhage, the patient is eligible for the study). 7. ich enlargement during the 6-hour stabilization period (6 hour after ivc placement). 8. internal bleeding, involving retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts. 9. superficial or surface bleeding, observed mainly at vascular puncture and access sites (e.g., venous cutdowns, arterial punctures) or site of recent surgical intervention. 10. known risk for embolization, including history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis, and subacute bacterial endocarditis. 11. prior enrollment in the study. 12. any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated. 13. participation in another simultaneous medical investigation or trial.

Keywords: intraventricular hemorrhage (ivh) rt-pa